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Regulatory Approvals

small-blue-tahNEW70cc SynCardia temporary Total Artificial Heart


Indication:
For use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

HUD for Destination Therapy
The U.S. Food and Drug Administration (FDA) has approved a Humanitarian Use Device (HUD) designation for the SynCardia Total Artificial Heart to be used for destination therapy in addition to its current approval as a bridge to transplant.
›› learn more

50cc Total Artificial Heart - Under Development

The 50cc Total Artificial Heart is a smaller version of the 70cc Total Artificial Heart. It is designed for use in patients of smaller stature, including women and adolescents, who have a BSA between 1.2 and 1.79m². ›› learn more

IDE Clinical Study: SynCardia plans to conduct an Investigational Device Exemption (IDE) clinical study of the 50cc Total Artificial Heart in the U.S. The 50cc TAH study will feature three arms:

  1. Bridge to transplant in adult patients
  2. Destination therapy in adult patients
  3. Bridge to transplant in pediatric patients

 

Drivers

c2frontwscreenCompanion 2 hospital driver

- European CE Mark: July 25, 2011
- FDA approval: July 5, 2012


›› Learn more

fdriverFreedom® portable driver*

- European CE Mark: March 1, 2010
- Health Canada: May 25, 2011
- FDA approval: June 26, 2015
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››
Learn more

 

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SynCardia
Total Artificial Heart


Characteristics:
    • Replaces both ventricles
    • No surgical pocket required
    • For use in patients with a BSA of 1.7 m² or greater
    • Highest cardiac output through both ventricles - up to 9.5 L/min
    • Stroke volume is 70 ml
    • Weighs 160 grams
    • Blood flow path is the same as the human heart
    • Shortest blood path (< 20 cm) of any mechanical circulatory support device

›› The Total Artificial Heart

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NEXT ›› Reimbursement

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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